Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT01268995
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed NODAT defined by pathologic OGTT (2h, 75mg glucose):
glucose ≥ 200mg/dl
* Defect in insulin secretion as judged by OGTT and HOMA B
* Renal transplantation (deceased or living donor) and treatment with the standard immunosuppression at our center, consisting of tacrolimus, mycophenolate mofetil, prednisone triple therapy without any induction
* stable graft function for more than 3 months post transplant
* informed consent of the patient
Exclusion Criteria:
* patients with prior history of type 1 or type 2 diabetes
* time since transplantation more than 20 years
* allergy against long-acting insulin or cyclosporine A
* body mass index (BMI) \> 35
* pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01268995
Study Brief:
Protocol Section:
NCT01268995